biostudies-literatureUnknown12(1)Devine JKAxsome TherapeuticsJazz Pharmaceuticals<h4>Introduction</h4>Excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA) can impair vigilance/attention. Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved to treat EDS associated with narcolepsy (75-150 mg/day) or OSA (37.5-150 mg/day). The analysis reported here explored the use of the Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) model (used in transport industries to model performance based on accumulated sleep and circadian variability) as a substitute for healthy controls using psychomotor vigilance task (PVT) data collected during clinical studies.<h4>Methods</h4>Data were analyzed from two phase 2 studies of solriamfetol in adults with OSA (NCT02806895, EudraCT 2015-003930-28) or narcolepsy (NCT02806908, EudNeurology and therapy249-265https://www.ebi.ac.uk/biostudies/studies/S-EPMC9837359biostudies-literaturePsychomotor Vigilance Performance in Participants with Excessive Daytime Sleepiness in Obstructive Sleep Apnea or Narcolepsy Compared with SAFTE-FAST Model Predictions.PMC9837359Janssen HCarter LPLammers GJde Vries NRamaekers JGOvereem SWang GSchwartz LVinckenbosch FHursh SChen DAsin JDonjacour CEHMDevine JKVonk PEVermeeren AfalsePsychomotor Vigilance Performance in Participants with Excessive Daytime Sleepiness in Obstructive Sleep Apnea or Narcolepsy Compared with SAFTE-FAST Model Predictions.<h4>Introduction</h4>Excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA) can impair vigilance/attention. Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved to treat EDS associated with narcolepsy (75-150 mg/day) or OSA (37.5-150 mg/day). The analysis reported here explored the use of the Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) model (used in transport industries to model performance based on accumulated sleep and circadian variability) as a substitute for healthy controls using psychomotor vigilance task (PVT) data collected during clinical studies.<h4>Methods</h4>Data were analyzed from two phase 2 studies of solriamfetol in adults with OSA (NCT02806895, EudraCT 2015-003930-28) or narcolepsy (NCT02806908, Eud2023-01-01T00:00:00Z2023 Feb2026-05-28T11:52:29.637Z2025-04-07T03:19:00.563ZS-EPMC98373593649459110.1007/s40120-022-00425-w